(184 days)
The Gerson 1730 N95 Particulate Respirator is intended to be worn by operating room personnel during healthcare procedures to protect both the patient and healthcare professionals from the transfer of microorganisms, bodily fluids and particulate material.
This device also meets CDC guidelines for TB exposure.
Subject device is also a surgical mask and is single use / disposable.
The 1730 N95 Particulate Respirator and Surgical Mask is constructed from a white nonwoven material used for the inner and outer shell. The polypropylene meltblown filter media is layered between the inner and outer shell. The headband is made of elastic and welded to the mask. The inside nosepiece is made of an open celled foam and the outside nosepiece, which conforms to the nose, is made of aluminum.
The 1730 N95 Particulate Respirator is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The N95 must meet the prescribed test criteria of a 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per the ASTM D583-65 Method 1 and is resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per 42 CFR 84.
The provided text describes a 510(k) premarket notification for the "Gerson 1730 N95 Particulate Respirator," which is seeking substantial equivalence to a predicate device. This document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria in the way typically found for software or AI/ML devices with specific performance metrics (e.g., sensitivity, specificity).
Instead, this document focuses on confirming that the N95 respirator meets regulatory standards and performance equivalence for a physical product. The "acceptance criteria" here are defined by the required performance for an N95 respirator and surgical mask designation, and the "study" refers to the testing performed to demonstrate these physical properties.
Here's a breakdown based on the provided text, adapted to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Particulate Filtration Efficiency (NIOSH N95) | 95% efficiency against a 0.3 micron diameter challenge | Meets prescribed test criteria of a 0.3 micron diameter challenge, requiring 95% efficiency. Certified by NIOSH with certification number TC-84A-160 for a type N95 Particulate Respirator. The device incorporates a highly efficient filter media and is 95% efficient against a 0.3 micron particulate size. |
| Fluid Resistance (Surgical Mask) | Resistance to synthetic blood | Fluid resistant as per ASTM D583-65 Method 1. Resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. |
| Breathing Resistance | Not explicitly quantified, but must meet standards | Tested as per 42 CFR 84. (Assumed to meet standards, as no issues reported.) |
| CDC Guidelines for TB Exposure Control | Compliance with guidelines | Meets CDC Guidelines for TB Exposure Control. |
| Disposable Single Use | Disposable | Described as a disposable single use mask. |
| Substantial Equivalence (Overall) | Comparable in manufacturing, materials, and performance | Found substantially equivalent to the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735. Manufactured in the same manner with minor material/construction differences (welded elastic headbands vs. stapled rubber, open-celled foam vs. closed-cell foam), while maintaining the same efficiency. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size for the test set" in the context of clinical data or image sets. It refers to a physical product undergoing standardized testing.
- For Particulate Filtration Efficiency and Breathing Resistance: These tests are conducted according to NIOSH standards (42 CFR 84). The sample size for such physical product testing is typically defined by the standard and involves a set number of units. The document does not explicitly state the number of units tested but implies compliance with the standard which would dictate this.
- For Fluid Resistance: "Protocol number 9602202-01 conducted by Nelson Laboratories." While the specific number of masks tested isn't given, Nelson Laboratories is a reputable testing facility, implying adherence to their established protocols for sample size.
- Data Provenance: The testing was performed by NIOSH (for N95 certification) and Nelson Laboratories (for fluid resistance). This implies controlled laboratory settings and not human subject data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device. The "ground truth" for a physical respirator's performance is established through objective, standardized engineering and material science tests, not through expert clinical consensus for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or adjudication involved in the objective measurements of filtration efficiency, fluid resistance, or breathing resistance. These are direct measurements comparing physical properties to established benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a physical N95 respirator, not an AI/ML-based diagnostic or assistive device. Therefore, no MRMC studies or AI assistance are relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical N95 respirator, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Standardized Test Methods and Criteria: Primarily NIOSH (National Institute for Occupational Safety and Health) standards for N95 respirators (42 CFR 84) and ASTM (American Society for Testing and Materials) standards (ASTM D583-65 Method 1) for fluid resistance.
- Predicate Device Performance: Demonstrating that the new device performs equivalently to a legally marketed predicate device (Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735).
8. The Sample Size for the Training Set
Not applicable. This is a physical product and does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no corresponding establishment of ground truth for a training set.
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510 (k) Summary
Submitter:
Louis M. Gerson Co., Inc. i 5 Sproat Street Middleboro, MA 02346
Contact:
Robert A. Brunell Regulatory Affairs Manager tel: 508-923-2145 or 508-947-4000 fax: 508-947-9205
Date: November 15, 2006
Trade Name:
1730 N95 Particulate Respirator
Common Name:
l 730 N95 Particulate Respirator
Classification:
Device Class - Class II CFR Section - 21 CFR 878.4040
Substantial Equivalency:
The 1730 N95 Particulate Respirator and Surgical Mask is found to be substantially equivalent to the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735. The product is manufactured in the same manner, with the exception of welded elastic headbands and open celled foam as opposed to stapled rubber headbands with a closed cell foam. It is a fluid resistant, disposable single use mask.
NOV 1 7 2006
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Description:
The 1730 N95 Particulate Respirator and Surgical Mask is constructed from a white nonwoven material used for the inner and outer shell. The polypropylene meltblown filter media is layered between the inner and outer shell. The headband is made of elastic and welded to the mask. The inside nosepiece is made of an open celled foam and the outside nosepiece, which conforms to the nose, is made of aluminum.
The 1730 N95 Particulate Respirator is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The N95 must meet the prescribed test criteria of a 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per the ASTM D583-65 Method 1 and is resistant to synthetic blood as per protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per 42 CFR 84.
Intended Use:
The 1730 N95 Particulate Respirator and Surgical Mask is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate matter.
This device also meets CDC Guidelines for TB Exposure Control.
Limitations:
This product does not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids. It is a disposable single use mask.
Comparison of Predicate Device:
The outside cover stock of the previously cleared device is white, as is the 1730 N95 Particulate Respirator. The 1730 has welded elastic headbands similar to the 2735's stapled rubber headbands. The 1730 uses an open celled foam comparable to the 2735's closed cell foam.
The 1730 N95 Particulate Respirator and Surgical Mask incorporates a highly efficient filter media and is 95% efficient against a 0.3 micron particulate size, which was scientifically established as the most penetrating particle size. The previously cleared device had the same efficiency.
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Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is displayed in a simple, sans-serif font. The words are arranged horizontally, with 'Public Health' on the first line and 'Service' on the second line.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert Brunell Manager of Regulatory Affairs Louis M. Gerson Company, Incorporated 15 Sproat Street Middleboro, Massachusctts 02346
NOV 17 2006
Re: K061375
Trade/Device Name: Gerson 1730 Type N95 Particulate Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: September 27, 2006 Received: November 7, 2006
Dear Mr. Brunell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Brunell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Syndite Y. Michie Ond.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K061375
Device Name: Gerson 1730 Type N95 Particulate Respirator
Indication For Use:
The Gerson 1730 N95 Particulate Respirator is intended to be worn by operating room personnel during healtheare procedures to protect both the patient and healthcare professionals from the transfer of microorganisms, bodily fluids and particulate material.
This device also meets CDC guidelines for TB exposure.
Subject device is also a surgical mask and is single use / disposable.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) X
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON OTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule H. Murphy, MD
Origin Gil)
an of Anesthesiology, General Hospital,
ion Control, Dental Devices
K04/375
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.